Kornimate/medical-research-clean huggingface dataset:
actovegin 12-week treatment given first intravenously and subsequently orally in participants with peripheral arterial occlusive disease fontaine stage iib

Conditions: Peripheral Arterial Diseases

Summary: the purpose of the study is to evaluate the efficacy and safety of actovegin in participants with peripheral arterial disease (pad) fontaine stage iib.

the study will enroll approximately 366 participants. participants will be randomly assigned to one of the two treatment groups in 1:1 ratio: 1. actovegin 2. placebo (dummy inactive substance) - this is a tablet/intravenous infusion that looks like the study drug but has no active ingredient all participants will be asked to take intravenous infusion for 2 weeks followed by oral tablets for 10 weeks. this multi-center trial will be conducted russia, georgia, and kazakhstan. the overall time to participate in this study is 25 to 26 weeks. participants will make multiple visits to the clinic, and 12 weeks after last dose of study drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: 1. has a history of stable intermittent claudication lasting more than 6 months before screening. 2. has a diagnosis of peripheral arterial disease (pad) (code i70.2 according to the international classification of diseases-10th revision) fontaine stage iib confirmed by ultrasound color duplex imaging. 3. has a resting doppler ankle-brachial index of less than or equal to (\<=) 0.9. 4. has intermittent claudication with initial claudication distance (icd) less than (\<) 200 meters. 5. is not newly diagnosed with pad and has a history of stable pad therapy for at least 2 weeks before screening. exclusion criteria: 1. has pad fontaine stage iii or iv (pain at rest, non-healing ulceration, or gangrene). 2. has evidence of nonatherosclerotic pad. 3. has greater than (\>) 25 percent (%) variability in absolute claudication distance (acd) based on treadmill testing during the screening period. 4. has lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within 3 months before screening. 5. is eligible for surgical/interventional reconstruction. 6. had a myocardial infarction or major cardiac surgery within 3 months before screening. 7. has congestive heart failure (new york heart association class iii/iv). 8. has uncontrolled diabetes mellitus (glycosylated hemoglobin \[hba1c \>9%\]) or diabetic polyneuropathy. 9. has any other illness that significantly limits exercise capacity or other medical condition, including any psychiatric disorder that limits participation (in the judgement of the investigator). 10. the subject has received any prohibited medication within 14 days before randomization (day 1) 11. the subject is undergoing the supervised exercise training program by the time of screening and is going to continue this program due to its effectiveness.

Keywords: drug therapy
18-month study of the efficacy of xaliproden (sr57746a) in patients with mild-to-moderate dementia of the alzheimer's type

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate alzheimer's disease. the patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease using nincds-adrda criteria * mild to moderate degree of severity of dementia as assessed by the mini-mental state examination score of 16 to 26 (inclusive) * potential participant may be treated with conventional alzheimer's disease therapy and must be on stable dose for at least 6 months prior to the randomization and during the entire study period * potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility * mother tongue is english, spanish or french (oral and written fluency) * signed informed consent from potential participant or legal representative and identified caregiver exclusion criteria: * potential participant with any other cause of dementia. * potential participant with serious health problems other than alzheimer's disease * use of an investigational drug within two months prior to randomization or during this study
sabr combined with axitinib and toripalimab in recurrent or metastatic rcc

Conditions: Radiation Therapy; Targeted Therapy; Immunotherapy; Renal Cancer Metastatic

Summary: this is a prospective, single-center clinical trial designed to evaluate the safety and efficacy of combining stereotactic ablative body radiotherapy (sabr) with the targeted therapy axitinib and the immunotherapy toripalimab in patients with recurrent metastatic renal cell carcinoma (rcc). patients will receive a treatment regimen consisting of axitinib, toripalimab, and comprehensive multi-lesion sabr. the primary endpoint is progression-free survival 1 (pfs1), and secondary endpoints include progression-free survival 2 (pfs2), overall survival (os), local control (lc), objective response rate (orr), and disease control rate (dcr). adverse events will be monitored according to the common terminology criteria for adverse events (ctcae 5.0). the aim of this study is to explore a potentially more effective treatment combination for recurrent metastatic rcc.


Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by pet/ct or other systemic imaging. 2. patients with ≤5 metastatic lesions amenable to complete lesion coverage radiotherapy; or \>5 lesions with at least 3 suitable for radiotherapy as evaluated by the radiotherapy and imaging departments. 3. age between 18-80 years. 4. expected survival of ≥12 weeks. 5. measurable disease based on recist version 1.1. 6. ecog performance status of 0-2. exclusion criteria: 1. history of anti-pd-1 or pd-l1 antibody therapy, or radiotherapy. 2. use of corticosteroids or other immunosuppressants within 14 days before treatment. 3. autoimmune diseases. 4. history of other malignancies. 5. history of surgery within 28 days before treatment. 6. allergy to study drug components.
to evaluate the immunogenicity and safety of two different immunization schedules of rabies vaccine (vero cell)

Conditions: Rabies Human

Summary: to evaluate the safety and immunogenicity of lyophilized human rabies vaccine (vero cell) developed by hualan biological in healthy people aged 9 to 65 years with two different immunization schedules.

the trial to assess the rabies vaccine (vero cells) in healthy group of 9 \~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; the safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. more people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, gmc and gmc growth multiples have differences. to evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.

Eligibility criteria:
inclusion criteria: * 9 to 65 years old healthy residents; * volunteered for the experiment and signed informed consent; * the subjects or their guardians can comply with the requirements of the clinical trial protocol; * have not received rabies vaccination at any time; * nearly six months has not been mammals bite, scratch; * not participating in clinical trials of other drugs; * no use of human immunoglobulin or other products in the past six months. exclusion criteria: first needle exclusion: * have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy; * allergic to the main ingredient of the investigational vaccine; * known to people with poor immune function damage or the tumor, spleen; * axillary temperature \>38.0℃ within 7 days due to acute febrile illness; * patients with axillary body temperature \> 37.0℃; * severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors; * patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases; * pregnant and lactating women; any circumstances that the investigator believes may affect the assessment of the trial. subsequent needle exclusions: * any serious adverse event causally related to vaccination; * new findings that meet the "first dose exclusion criteria"; * the researchers think that may affect test evaluation of any situation.

Keywords: antibody titer
clinical evaluation of cast21 short arm product during treatment of distal radial or distal ulnar fractures

Conditions: Fractures, Closed; Fractures Bone; Fracture; Fractures; Radius; Fracture, Lower or Distal End; Ulna Fractures; Radius Distal Fracture

Summary: the primary objective of this study will be the collection of preliminary clinical evidence to indicate that cast21 short arm product is no worse than the current standard of care arm immobilization devices in pediatric patients. a secondary objective will be to characterize the clinician and patient experience with the cast21 short arm product.


Eligibility criteria:
inclusion criteria: * demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study * medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury * sizing: participants eligible for the cast21 short arm product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes xs-l) exclusion criteria: * participants requiring a surgical intervention * participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure. * participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions * participants with pathologic fractures e.g., presence of bone cyst * participants who smoke * participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion)
phase 2 study of hec88473 injection in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: this is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with t2dm. patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. approximately 225 participants will be randomized. the study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).


Eligibility criteria:
inclusion criteria: 1. male or female patients 18 to 75 years of age, inclusive. 2. have t2dm for at least 3 months before screening based on the disease diagnostic criteria (who 1999). 3. have an hba1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmol/l, at screening and visit 3. exclusion criteria: 1. have type 1 diabetes mellitus. 2. have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months). 3. have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine aminotransferase (alt) level \>2.5 times the upper limit of the reference range at screening. 4. have a personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2) at screening. 5. have serum calcitonin ≥20 ng/l at screening. 6. fasted triglycerides \> 5.7 mmol/l at screening.
training and coaching to promote high performance in veteran affairs (va) nursing home care

Conditions: Dementia

Summary: this study aimed to explore the feasibility of an educational intervention to strengthen workplace learning systems in four va community living centers (clcs).

background: the study explored the feasibility of an educational intervention to strengthen workplace-learning systems in four va community living centers (clcs). objectives: specific aims were to 1) conduct a feasibility study to assess whether the educational intervention is practical to implement as designed and 2) conduct a pilot study to validate the methodology proposed for assessing outcomes of this educational intervention. methods: a multi-level intervention targeting the translation of workplace learning into practice was implemented. the direct care worker (dcw) intervention targeted both clinical knowledge and effective communication. the coaching supervision training addressed management and supervision practices for nurses, combined with effective communication. four clcs received both interventions, administered by the paraprofessional health institute (phi), using a train-the-trainer approach over the course of four 3-day sessions. quantitative and qualitative data were collected to assess factors influencing effectiveness of implementation and to understand the impact of the trainings on participants. status: the study has been completed with educational interventions implemented and qualitative and quantitative data collected.

Eligibility criteria:
inclusion criteria: * va employees: psychologists, nurse-managers and front-line nursing care staff assigned to clcs will be included exclusion criteria: * those not working in the clc, * those working in the clc but not involved in the training intervention that is the focus of the study (e.g. environment management service personnel, dietary personnel)

Keywords: nursing homes implementation of innovative programs nursing staff nurses' aides educational models
ecologically valid virtual tasks vs paper-pencil methods in cognitive rehabilitation in patients with schizophrenia and depression

Conditions: Schizophrenia; Depression; Cognitive Impairment

Summary: schizophrenia is heterogeneous and often disabling a disease that affects 1% of the population. current psychopharmacological treatment significantly eliminates the presence of positive symptoms (especially delusions and hallucinations) and partly also negative symptoms (social withdrawal or abulia). in contrast, the cognitive deficits associated both with schizophrenia and depression are only limitedly influenced by pharmacological treatment.the cognitive impairment represents an important part of schizophrenia symptomatology and it has a severe negative impact on patients' quality of life. in depression is the impairment milder but still significantly contributes to patients' daily functioning. the profound deficit was repeatedly documented in the area of declarative and working memory. in this study, we study the effectiveness of virtual environment rehabilitation program focused on declarative memory, working memory and attention in comparison to standard paper-pencil rehabilitation led by an occupational therapist.

this study compares effectiveness of the virtual environment cognitive rehabilitation program with standard paper-pencil approach in within-subject design. participants with a diagnosis of schizophrenia, schizoaffective disorder or major depressive disorder will undergo a baseline assessment of cognition. the participants will be at the baseline randomly assigned to each condition: virtual environment rehabilitation or paper-pencil rehabilitation. then they will participate in 10-15 sessions (30-45 minutes) once or twice a week. all participants will undergo retest assessment of cognition. after completion of the first program the participants will be assigned to the different condition: to paper-pencil or virtual environment rehabilitation. after 10-15 sessions in the second condition the participants will once more undergo retest assessment of cognition. within-subject design is an effective tool in the development of scientifically proven treatment tools. this approach allows to obtain reliable information about the effectiveness of the method and to examine the influences of other variables (steingrimsdottir and arntzen 2015). this study will allow to get credible information on the importance of using the virtual environment in the context of cognitive rehabilitation in patients with schizophrenia and depression.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia and other primary psychotic disorders or diagnosis of major depressive disorder according to international classification of diseases-11 exclusion criteria: * severe visual impairment * age over 60 years * diagnosis of other psychiatric disorder than schizophrenia or major depressive disorder * physical handicap preventing the participant from participating in virtual environment training * refusal to sign an informed consent

Keywords: cognitive deficit schizophrenia major depressive disorder virtual environment cognitive rehabilitation
clock and narcolepsy genetic variants and the effects of stalevo® (levodopa/carbidopa/entacapone) on sleep disorders in parkinson's disease

Conditions: Parkinson Disease; Sleep Disorders

Summary: the purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of stalevo® on the quality of sleep in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with pd in accordance with uk parkinson's disease society brain bank clinical diagnostic criteria (hughes aj, et al. 1992). 2. patients with pd who have wearing off phenomenon. 3. patients with pd with hoehn and yahr stage 1-4. 4. patients with pd who have sleep problems (pdss score ≤120 or epworth sleepiness scale(ess) score ≥ 8). 5. patients with pd who showed montreal cognitive assessment (moca) score ≥15. 6. patients with pd who have no major depression (geriatric depression scale, gds ≤ 24) exclusion criteria: 1. secondary parkinsonism 2. parkinson-plus syndromes (multiple system atrophy, progressive supranuclear palsy, and corticobasal degeneration. 3. patients with pd who have history of severe side effect of stalevo®.

Keywords: stalevo sleep disturbance central circadian clock narcolepsy
regulatory b cells in inflammatory rheumatisms and biomarkers of response to biologic treatments

Conditions: Rheumatoid Arthritis; Osteoarthritis; Systemic Lupus Erythematosus; Sjogren's Syndrome; Scleroderma; Spondylitis; Gout; Spinal Disease; Chondrocalcinosis

Summary: b cells are known to play an important role in auto-immune diseases by activating t cells, secreting inflammatory cytokines and autoreactive antibodies. however, a sub-type of b cells named regulatory b cells or bregs has recently shown capacities to prevent or cure arthritis in mouse models. bregs have also been identified in humans.

b cells are known to play an important role in auto-immune diseases by activating t cells, secreting inflammatory cytokines and autoreactive antibodies. however, a sub-type of b cells named regulatory b cells or bregs has recently shown capacities to prevent or cure arthritis in mouse models. bregs have also been identified in humans. main objective: to study bregs abnormalities in patients with rheumatoid arthritis (ra) at different stages of the disease compared to subjects with mechanical pathologies.secondary objectives:- to evaluate the specificity of any abnormalities identified in ra by studying bregs in patients with other autoimmune or other inflammatory joint diseases.- to evaluate the effect of biological and synthetic treatments on bregs in patients with ra. - to assess whether the rate of bregs before treatment is predictive of response to biological and synthetic treatments.

Eligibility criteria:
inclusion criteria: for ra patients and control patients: * age over 18 year old * blood sample taken as part of the usual management * steroid less than or equal to 15 mg/day and stable for at least a week for ra patients: * patient with ra meeting the acr / eular 2010 for control patients: * patients with systemic autoimmune disease (lupus, sjogren's syndrome, scleroderma) or other inflammatory arthritis (spondylitis, crystals) or a mechanical pathology (limb osteoarthritis or spinal pathology) . exclusion criteria: * steroids over 15 mg/day * rituximab infusion in less than 12 months

Keywords: regulatory b cells rheumatoid arthritis biomarker
post-transplant cyclophosphamide and sirolimus following reduced intensity conditioning (ric) transplant

Conditions: Hematologic Neoplasms

Summary: this trial will evaluate the safety and efficacy of post-transplant cy and sirolimus following reduced intensity allogeneic sct. it is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free gvhd prophylaxis regimen will decrease the risk of acute and chronic gvhd, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. the past experience with post-transplant cy suggests that sct recipients will attain rapid donor t cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor t cells.


Eligibility criteria:
inclusion criteria: * availability of a 7/8 or 8/8 (hla-a, b, c, dr) related or unrelated donor * age 18-75 * one of the following high-risk malignancies * chronic myelogenous leukemia * acute myelogenous leukemia * myelodysplastic syndrome * myelofibrosis * acute lymphocytic leukemia * acute lymphoblastic lymphoma * chronic lymphocytic leukemia * prolymphocytic leukemia * low-grade non-hodgkin's lymphoma * mantle cell lymphoma * hodgkin lymphoma * myeloma exclusion criteria: * poor cardiac function (ef \<40%) * poor pulmonary function (fev1 and fvc \<50% predicted) * poor liver function (bilirubin \>/= 2 mg/dl not due to hemolysis, gilbert's or primary malignancy) * poor renal function (creatinine \>/= 2 mg/dl or creatinine clearance \<40ml/min) * karnofsky status \<70% * hiv positive

Keywords: chronic myelogenous leukemia acute myelogenous leukemia myelodysplastic syndrome myelofibrosis acute lymphocytic leukemia acute lymphoblastic lymphoma chronic lymphocytic leukemia prolymphocytic leukemia low-grade non-hodgkin's lymphoma mantle cell lymphoma hodgkin lymphoma myeloma
comparison across multiple types of sleep deprivation

Conditions: Sleep Deprivation; Sleep Restriction

Summary: this study is designed to assess neurobehavioral performance, as well as genetic and other physiological changes associated with variations in timing and quantity of sleep.

during a 1.5 week inpatient laboratory protocol, subjects will undergo one of four parallel sleep conditions. subjects will be randomly assigned to each condition group. during their time in the laboratory, biological samples (e.g., blood) will be collected for genetic and other analyses, and sleep quantity and quality will be monitored. additionally responses on neurobehavioral tests and surveys will be monitored for differences among the groups.

Eligibility criteria:
inclusion criteria: * healthy * bmi 18.5-29.9, with consideration of bmis 30-34.9. exclusion criteria: * medication use, with potential consideration for contraceptives. * color blindness * recent nightwork, shiftwork, or travel across greater than two time zones * pregnant or within 6 months post-partum

Keywords: neurobehavioral performance genetic